Lotrimin Af

NDA 20888, held by Schering Plough. Clotrimazole.

As of Nov 13, 2026, NDA 20888 (Lotrimin Af), held by Schering Plough, was first approved by FDA on Oct 27, 1989, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 27, 1989
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Oct 27, 1989	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lotrimin Af1% · cream; topical	Clotrimazole	OTCReference drug

All 7 submissions, including labeling and manufacturing supplements


Jan 16, 2002	Supplement 7Manufacturing	Approved	None posted
Aug 1, 2001	Supplement 2Labeling · Standard review	Approved	Label
Mar 8, 2001	Supplement 6Manufacturing	Approved	None posted
Feb 26, 2001	Supplement 5Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 4Manufacturing	Approved	None posted
Jun 9, 1998	Supplement 1Manufacturing	Approved	None posted
Oct 27, 1989	Original application	Approved	None posted

Identifiers

Application: NDA 20888
Drugs@FDA: Overview at FDA
Company: Schering-Plough

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters